Pathak 2013.
| Study characteristics | |
| Methods | Randomised controlled trial |
| Participants | Inclusion criteria: (quote:) "term or near term neonates (≥ 35 weeks of gestation) admitted with clinically apparent seizures not responding to treatment of hypoglycaemia, hypocalcaemia and other metabolic disorders. Clinical criteria for diagnosis of neonatal seizures were: (i) clonic movement which could be unifocal, multifocal or generalised (ii) tonic posturing with or without abnormal gaze (iii) subtle seizures and spontaneous paroxysmal, repetitive motor or autonomic phenomenon like lip‐smacking, chewing, paddling, cyclic movements or respiratory irregularities" Exclusion criteria: (quote:) "Seizures responding to correction of hypoglycaemia, hypocalcaemia or any other metabolic disorder, and babies with major congenital malformation or myoclonic jerks" PHT group, 55 patients Gestational age (wk), mean (SD): 38.6 (1.45) Weight (kg), mean (SD): 2.71 (0.4) Male sex: 39 (70.9) No of extramural deliveries: 30 (70.9) HIE stage 2: (n = 42) 21 (38.2) HIE stage 3: (n = 44) 26 (47.3) Cause of seizures Meningitis: (n = 18) 7 (12.7) Intracranial bleed: (n = 2) 1 (1.8) Kernicterus: (n = 4) 1 (1.8) Type of seizure Subtle: 27 (49) Tonic: 24 (43) Clonic: 6 (10.9) PB group, 54 patients Gestational age (wk), mean (SD): 38.09 (1.87) Weight (kg), mean (SD): 2.55 (0.5) Male sex: 40 (74.1) No of extramural deliveries: 36 (67.0) HIE stage 2: (n = 42) 21 (38.9) HIE stage 3: (n = 44) 18 (33.3) Cause of seizures Meningitis: (n = 18) 11 (20.4) Intracranial bleed: (n = 2) 1 (1.9) Kernicterus: (n = 4) 3 (5.6) Type of seizure Subtle: 24 (44) Tonic: 20 (37) Clonic: 8 (14) The study was conducted at a level II neonatal unit in Meerut, India from November 2008 to September 2009. |
| Interventions | Intravenous phenytoin, loading dose of 20 mg/kg administered over 30 minutes at a rate of 1 mg/kg/min. If seizure persisted, the babies were crossed over to intravenous phenobarbitone. Intravenous phenobarbitone, loading dose of 20 mg/kg administered over 30 minutes. If seizure persisted, the babies were crossed over to intravenous phenytoin. (Quote:)"If seizure persisted after two drugs, baby was reloaded with IV phenobarbitone at 10 mg/kg each to a maximum of 40 mg/kg and then a third‐line drug like midazolam was used IV at 0.1 mg/kg/dose." |
| Outcomes | Primary outcome: cessation of clinical seizure activity Secondary outcomes: (quote:) "(i) survival at discharge, (ii) neurodevelopment outcome at 3 months (Amiel‐Tieson method), (iii) time taken to control seizures, and (iv) EEG control of seizures." |
| Notes | According to the authors, there was no external funding. The authors reported not having potential conflicts of interest to disclose. |